Uppsala Reports Long Reads – Vaccination errors risk harm and damage trust

Medication errors with vaccines can harm individual patients, but when they also undermine trust in public health programmes, serious problems can ripple across entire communities – as the Samoan healthcare crisis of 2018 dramatically showed. The Institute for Safe Medication Practices offers straightforward advice that could prevent those errors from happening again.

This episode is part of the Uppsala Reports Long Reads series – the most topical stories from UMC’s pharmacovigilance magazine, brought to you in audio format. Find the original article here.

Tune in to find out:

• Which errors can occur in the vaccination process
• Why two-component vaccines are especially susceptible to administration errors
• How vaccine packaging and labelling can be improved to prevent errors

Want to know more?

The Institute for Safe Medication Practices has repeatedly warned about the risks with two-component vaccines. In 2015, they issued a position statement calling for safer design of vaccine packaging and labelling.

Tragic errors can occur when dangerous substances are accidentally used instead of the vaccine diluent, like the incident that occurred in Syria in 2014.

The measles outbreak that took root in Samoa as a consequence of vaccine hesitancy – which in turn stemmed from an earlier, tragic vaccination error – holds important lessons for the rest of the world.

Transcript

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SPEAKER_00 0:06

Welcome to Drug Safety Matters, a podcast by Uppsala Monitoring Center, where we explore current issues in pharmacovigilance and patient safety. My name is Federica Santoro, and this episode is part of the Uppsala Reports Long Reads series, where we select the most topical stories from our magazine, Uppsala Reports, and bring them to you in audio format. Our pick for today is the article Serious Errors with Two Component Vaccines, Risk Harm and Damage Trust. The article appeared on the Uppsala Reports online site in August 2020. Medication errors can harm individual patients. But when errors also undermine trust in public health programs, serious problems can ripple across entire communities. Take the tragic medication error in Samoa, which not only led to the death of two infants, it also eroded public trust in the national vaccination program. Luckily, Alison Hansen, Nista Shaw, and Michael Cohen from the Institute for Safe Medication Practices have straightforward advice that could stop this from happening again. Here's their story, read by Uppsala Report's editor Jared Ross.

SPEAKER_01 1:30

Safe use of vaccines is essential for the success of vaccination programs. However, as with medications, vaccination errors are known to occur. In particular, some vaccines are manufactured as two separate components that are combined at the time of administration, which can create a possibility for human error. And because of the role of vaccines in healthcare and the context in which they are perceived by the public, such errors have the potential for more wide-ranging consequences. A recent crisis in the Pacific Island Nation of Samoa illustrates how the effects of medication errors can cascade from personal tragedies to a national catastrophe. The vaccination process comprises several steps with a potential for errors at each one, including when vaccines are scheduled, ordered, prescribed, prepared, dispensed, and administered. Such errors can cause, for example, inadequate immunological protection, increased cost, inconvenience, patient harm, and even reduced confidence in the healthcare delivery system. Proper vaccine preparation and administration are important factors in preventing and eradicating many common vaccine preventable diseases. Errors made in preparing and administering vaccines may result in patients needing revaccination and health services suffering financial loss. In addition, if the errors are not realized and revaccination does not occur, patients may have an inadequate immune response and develop only poor protection against the disease. In either scenario, patients may lose confidence in both vaccines and healthcare providers. One area of concern regarding vaccination errors is when a particular vaccine requires the mixing of two components supplied by the manufacturer in physically separate containers. For example, some vaccines comprise a laophyllized or freeze-dried powder and a vaccine-specific liquid diluent, a diluting agent. Other vaccines may include a powder vial plus a liquid antigen vial or an adjuphant component. These powder and liquid containers may be packaged together by the manufacturer, or in some cases may arrive separately. To administer an effective dose, a healthcare worker must first prepare the vaccine by properly combining the two components. Unfortunately, in some cases the components are not mixed, meaning only one component of the two component vaccine is administered, possibly leading to the patient not becoming fully immunized. In other cases, an incorrect diluent is used to prepare the lyophyllised powder, which may affect the stability of the vaccine. In errors where only the diluent is administered, the patient develops no immunity at all. When these types of errors go undetected and revaccination does not occur, the patient is left at risk of developing the disease. In some tragic cases, dangerous substances have accidentally been used in place of the vaccine diluent. For example, there have been several reported incidents where a paralyzing agent, a neuromuscular blocker, has been used instead of a liquid diluent. In 2014, 15 children died in Syria after atricurium was used to reconstitute a measles vaccine. Apparently, the ampool packaging of atricurium was similar in appearance to that of the vaccine diluent, and a mix-up occurred. More recently, in Samoa, in July 2018, two infants died after receiving their measles, mumps, and rubella vaccine. Once again, it was discovered that atrocurium had been used to dilute the vaccine powder. As bad as that incident was for the infants and their families, worse was to come for the nation as a whole. Following intensive media coverage of the deaths and increased anti-vaccine advocacy, routine measles immunization rates in Samoa fell to just 31%, as parents became afraid to have their children vaccinated. Then, in October 2019, a measles outbreak took root and spread rapidly through the country. By December, in a population of just over 200,000, the outbreak had infected more than 4,300 people, claiming 70 lives, with 61 of the dead under five years old. Adding to the tragedy, the nurses responsible for the initial medication errors were convicted of homicide and sentenced to jail terms. While human error can never be eliminated, many factors that contribute to error can be identified and improved to minimize the chances of it occurring. In December 2015, the International Medication Safety Network, IMSN, issued a position statement calling for greater worldwide attention to the problem of unsafe design of vaccine packaging and labeling. The statement challenged healthcare professionals, pharmaceutical companies, technology vendors, professional organizations, and regulatory standard setting organizations to help improve vaccine safety and efficacy. In particular, the IMSN statement drew attention to the packaging and labeling of vaccines provided with diluents or two component vaccines, calling for packaging that forces proper mixing of the diluent or of the two components. For example, manufacturers could package the vaccine in a two-chambered syringe or vial. If that is not feasible, then vials of vaccine and diluent, or the second component, should be packaged together, unless that is not feasible, such as when the vaccine powder must be kept frozen, but its diluent must be stored at room temperature. In all cases, clear instructions must be communicated in or on the label for how to mix components of vaccines, such as displaying directions and a warning to administer contents of both vials together on the front label of each carton, vial, and vial cap. Also, the label of diluents must primarily and prominently identify them as such and make it clear that they are not the actual vaccine. For example, the labeling could show diluent for preparing, followed by the name of vaccine. Finally, healthcare authorities and regulators should promote safer labeling and packaging of vaccines, and make available to healthcare providers recommendations for safer vaccination practices. Errors preparing and administering two component vaccines can lead to inconvenience, increased costs, exposure to diseases, harm to patients, and even death. Furthermore, vaccination errors risk undermining public confidence in vaccination, which, as the Samoan outbreak starkly illustrates, can lead to dire public health outcomes. It is time for the medical community, including healthcare providers, their organizations, regulators, manufacturers, and health ministries, to come together to better address ongoing problems with two component vaccines through better packaging.

SPEAKER_00 8:36

If you'd like to know more about medication errors, check out the episode's show notes or visit upsalaports.org for more pharmacovigilance stories. If you like drug safety matters, subscribe to it via your favorite podcast player. And do send us comments and suggestions on social media. You'll find Uppsala Monitoring Center on Facebook, LinkedIn, and Twitter. And you can join the conversation there with the hashtag Drug SafetyMatters. This episode was produced by Matthew Barwick. We hope you enjoyed listening and hope you'll tune in again for the next episode. Bye for now!